Pilot Study of the IL-1 Antagonist Anakinra for the Treatment of Endometriosis Related Symptoms

• Status: Recruiting
• Trial end date: 2022-01-01
• Target enrollment: 0
• Participant gender: Female

Summary

All current FDA approved medications to treat endometriosis pain including danazol, GnRH agonists (Lupron, Zoladex and Synarel), GnRH antagonist (elagolix) and depo-provera prevent or contradict pregnancy. Therefore women suffering from endometriosis and trying to conceive have no medical options apart from pain meds. The purpose of this pilot study is to determine whether the anti-inflammatory, IL-1 inhibitor (anakinra) reduces pelvic pain due to endometriosis without altering menstrual cycles, which is an indicator of ovulatory function. Anakinra is an FDA approved injectable medication for the treatment of rheumatoid arthritis that is pregnancy category B.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, San Diego
• Treatments: Citric Acid; Interleukin 1 Receptor Antagonist Protein

Criteria

Inclusion Criteria:

• Women aged 18-45 with regular menstrual periods every 24-32 days and not lasting more than 10 days per month

• Surgical or imaging proven endometriosis.

• At least a moderate level of menstrual pain based on the patient reported parameters of the B&B pain scale (>4/9) with dysmenorrhea being scored at least 2/3.

• Willing to remain on your current method of hormone therapy for duration of study

Exclusion Criteria:

• History of hysterectomy or oophorectomy.

• Non-response to GnRH agonist/antagonist, DMPA, aromatase inhibitors or danazol.

• Currently pregnant or attempting pregnancy.

• Contraindication to anakinra.

• Chronic kidney disease stage 4 and 5 or creatinine clearance <30mL/min/1.73m2.

• Abnormal LFTs, CBC or serum electrolytes including estimated GFR.

• Patient refusal.

• Plan to receive a live vaccine